Canada: Safety and Effectiveness Requirements

Hello everybody and welcome back to another issue of MedTech Compliance Chronicles! Now that we have worked out how our device is classified in Canada, it is time to get into the bread and butter of Canadian medical device regulations (CMDR): Sections 10-20 of the CMDR, better known as the Safety and Effectiveness Requirements. When it comes to selling medical devices in Canada, everything ultimately points back to one principle: the device must be safe and effective when used as intended. While Health Canada’s classification system dictates the depth of regulatory review, the actual standard to which all devices are held are the safety and effectiveness requirements. These sections form the core expectations for safety and performance and apply to all medical devices regardless of risk class.

Whether you are submitting a license application, responding to a post-market inquiry, or investigating a complaint, demonstrating compliance with these general requirements is paramount to compliance with the CMDR. Essentially all regulatory action the minister of Health Canada is entitled to take regarding the sale of a medical device in Canada relates to the available evidence as to whether or not the device meets these requirements. In this post, we will unpack these core regulatory provisions, offering a clear understanding of what it means to design, manufacture, and market a compliant medical device in Canada.

Sections 10-20 of the CMDR, General Safety and Effectiveness Requirements

The heart of Canada’s medical device regulatory framework lies in Sections 10 through 20 of the CMDR, which establish the baseline requirements for safety and effectiveness that all devices must meet, regardless of their risk classification. These provisions are deeply interconnected, reflecting the understanding that a device cannot be truly effective if it is unsafe, nor can it be considered safe if it fails to perform its intended function reliably. These sections do not prescribe any particular test or format but instead define a clear set of expectations that form the legal and technical standard against which all medical devices are evaluated. Together, they create a comprehensive framework that spans a device’s design, intended use, compatibility with other systems, and performance throughout its usable life.

The foundational principle, articulated early in these sections, mandates that all medical devices must be designed and manufactured in a manner that does not compromise the health or safety of patients, users, or any other individuals when used as intended (this exact statement essentially being section 11). This overarching obligation requires a thorough risk management process, where potential hazards are systematically identified, their risks are evaluated, and appropriate control measures are implemented to minimize any adverse outcomes. Section 10 of the CMDR formally lays out the requirement for risk management, and prescribes a process of risk mitigation mirroring ISO 14971:2019. Section 12 lays out formal requirements that the device perform as intended by the manufacturer, to treat / mitigate / diagnose, etc. the illnesses / injuries claimed by the manufacturer, and section 13 extends this requirement over the entire useful life of the device, as defined by the manufacturer. 

Sections 14, 15, 16 and 17 all call out specific risks that must be considered for every medical device. Namely, those risks associated with material selection and compatibility, transport and storage and sterility. All materials incorporated into a medical device or used in their manufacture must be evaluated for compatibility with all other materials they may come into contact with during their lifecycle, including biological materials (biocompatibility), and demonstrate that no adverse effects arise from material interactions. Additionally, medical devices must be able to withstand anticipated conditions of transport and storage. This includes intentionally designing the packaging to mitigate any identified risks that could occur as a result of the distribution process. Finally, if the device is meant to be supplied sterile, the manufacturing processes must be controlled to ensure sterility upon delivery. This is typically done via validation of packaging processes for packing and sealing the sterile barrier systems and the sterilization process itself, however, depending on the specific product, can involve activities such as implementing aseptic processing in-house. 

The final three safety and performance requirements all relate to specific scenarios to be considered. Section 18 defines requirements to ensure that the device maintains its safety and efficacy even when connected to any accessories, networks or systems that it is meant to be connected with. While this requirement may seem obvious, it is can be quite appalling the number of devices that are not even actually tested with common accessories, if the manufacturer of the device does not also manufacture the accessories (i.e., TENS muscle stimulators indicated for use with off-the-shelf stimulations pads). Section 19 requires that any measurement function a device performs is capable of performing that measurement to the required accuracy for the particular medical condition to be treated / diagnosed. Finally, section 20 lays out the software validation requirements for all software that is incorporated into (or is) a medical device. 

Together, these sections of the CMDR form a comprehensive and interconnected set of expectations that address not only how a device is designed and performs on day 1, but also how it will function under stress, over time, and across different environments. Importantly, they also act as the reference point during Health Canada’s evaluation of a device’s supporting evidence. Manufacturers must be able to demonstrate how their design, risk management, labeling, and performance data align with each of these regulatory elements. Whether the evidence comes from bench tests, clinical studies, biocompatibility evaluations, or stability data, the standard remains the same: prove that the device will be both safe and effective for the intended user in the real world.

Conclusions

Sections 10 through 20 of the CMDR serve as the backbone of Canadian medical device regulation. They establish a universal baseline that protects patient safety and delivers reliable performance. Unlike classification rules or license application procedures, which vary by device type and risk, these general requirements are always in effect. They not only guide product development but also form the foundation of regulatory enforcement, inspections, and post-market expectations. Understanding and integrating these safety and performance requirements early in your product development process is essential for regulatory success in Canada. These requirements provide the blueprint for compliant design, manufacturing, and clinical assurance. In the coming posts, we will continue our journey into Canadian regulations by exploring how Health Canada regulates devices and what is required to obtain and maintain market authorization.